ObesitySOMNCT00716222
Hormonal and Metabolic Consequences of Sleep Disorders in Young Obese Patients
An observational study of Obesity and Sleep Disorders, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
There is a well-documented relationship between short sleep duration and high body mass index (BMI). The mechanism linking short sleep duration and weight gain is unknown. Current studies in healthy young volunteers have shown that experimental sleep restriction is associated with dysregulation of the neuroendocrine… Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Obesity, Sleep Disorders
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- May 2008to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients of the output clinics in the endocrinology and pediatric endocrinology departments at the university hospital.
Who may be able to join
- 13-25 years old
- BMI > 30 kg/m2 (If adolescents aged under 18 years: BMI equivalent to a BMI for age and sex to a BMI of 30, according to the Cole et al. obesity criteria).
Who cannot join
- Infection
- Liver disease
- Chronic inflammatory disease
- Endocrine disease
- Use of drugs that alter the sensitivity of insulin
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint Luc
Brussels, Brussels Capital, 1200
Veronique VB Beauloye, PhD, +3227641370, Veronique.Beauloye@uclouvain.be
About this study
There is a well-documented relationship between short sleep duration and high body mass index (BMI). The mechanism linking short sleep duration and weight gain is unknown. Current studies in healthy young volunteers have shown that experimental sleep restriction is associated with dysregulation of the neuroendocrine control of appetite and with alterations in glucose metabolism. The goal of our study is to determine the metabolic and hormonal modifications induced by chronic sleep curtailment in obese adolescents and young adults and to observe if short sleep is a negative prognostic factor in their weight evolution.
Read the detailed description
The main purpose of the study is investigate whether the concentrations of 2 hormones that regulate appetite (leptin, ghrelin), cytokines (TNF-a, IL-6) and CRP are modified in obese adolescents and young adults who had sleep disorders in comparison to obese adolescents and young adults who sleep longer.
- Conditions
- Obesity, Sleep Disorders
- Medical subject headings
- Obesity, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Obese adolescent and young adult with sleep disorder | |
| 2 | Obese adolescent and young adult without sleep disorder | |
| 3 | Lean adolescent and young adult with sleep disorder |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startMay 2008
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Veronique Beauloye, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716222
- Sponsor's protocol ID
- B40320084032
- Acronym
- SOM
- Status last verified
- Jan 2009
- First submitted
- 15 Jul 2008
- Last updated
- 21 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal and Metabolic Consequences of Sleep Disorders in Young Obese Patients
- ClinicalTrials.gov ID
- NCT00716222
- Acronym / sponsor ID
- SOM / B40320084032
- Conditions
- Obesity, Sleep Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- May 2008
- Study completion
- May 2009 (estimated)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a well-documented relationship between short sleep duration and high body mass index (BMI). The mechanism linking short sleep duration and weight gain is unknown. Current studies in healthy young volunteers have shown that experimental sleep restriction is associated with dysregulation of the neuroendocrine control of appetite and with alterations in glucose metabolism. The goal of our study is to determine the metabolic and hormonal modifications induced by chronic sleep curtailment in obese adolescents and young adults and to observe if short sleep is a negative prognostic factor in their weight evolution.
Detailed description
The main purpose of the study is investigate whether the concentrations of 2 hormones that regulate appetite (leptin, ghrelin), cytokines (TNF-a, IL-6) and CRP are modified in obese adolescents and young adults who had sleep disorders in comparison to obese adolescents and young adults who sleep longer.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Obese adolescent and young adult with sleep disorder |
| 2 | – | –Obese adolescent and young adult without sleep disorder |
| 3 | – | –Lean adolescent and young adult with sleep disorder |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients of the output clinics in the endocrinology and pediatric endocrinology departments at the university hospital.
Key inclusion criteria (2 listed)
- 13-25 years old
- BMI > 30 kg/m2 (If adolescents aged under 18 years: BMI equivalent to a BMI for age and sex to a BMI of 30, according to the Cole et al. obesity criteria).
Key exclusion criteria (5 listed)
- Infection
- Liver disease
- Chronic inflammatory disease
- Endocrine disease
- Use of drugs that alter the sensitivity of insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronique Beauloye, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Sleep Disorders, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veronique VB Beauloye, PhD (+3227641370, Veronique.Beauloye@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2009; AzTrials last refreshed its copy on 8 Nov 2026.